NCT02421705 Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)
| NCT ID | NCT02421705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KU Leuven |
| Condition | IBS |
| Study Type | INTERVENTIONAL |
| Enrollment | 99,999,999 participants |
| Start Date | 2010-03-12 |
| Primary Completion | 2099-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 99,999,999 participants in total. It began in 2010-03-12 with a primary completion date of 2099-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aim: More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.
Eligibility Criteria
Inclusion Criteria: For group 1: IBS 1. Irritable Bowel Syndrome (IBS) (ROME III criteria) 2. No obvious organic explanation for the IBS symptoms 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study Group 2: active ulcerative colitis 1. diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy) 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study Group 3: ulcerative colitis in remission (3a: with IBS symptoms, 3b: without IBS symptoms) 1. diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy) 2. remission is confirmed by at least one sigmoidoscopy 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study Only for group 3a: 4. Rome III criteria for IBS Group 4: Healthy controls No abdominal (pain) complaints. Group 5: active Crohn's disease 1\. diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy) 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study Group 6: Crohn's disease in remission (6a: with IBS symptoms, 6b: without IBS symptoms) 1. diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy) 2. remission is confirmed by at least one sigmoidoscopy 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study Exclusion Criteria: For all groups: 1. co-morbidity: severe kidney- and/or liver disease or thyroid abnormalities and impaired clotting 2. Abdominal chirurgy (except for an uncomplicated appendectomy)
Contact & Investigator
Guy Boeckxstaens, MD
PRINCIPAL INVESTIGATOR
Catholic University Leuven and Universitary Hospitals Leuven
Frequently Asked Questions
Who can join the NCT02421705 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying IBS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02421705 currently recruiting?
Yes, NCT02421705 is actively recruiting participants. Contact the research team at koen.bellens@kuleuven.be for enrollment information.
Where is the NCT02421705 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT02421705 clinical trial?
NCT02421705 is sponsored by KU Leuven. The principal investigator is Guy Boeckxstaens, MD at Catholic University Leuven and Universitary Hospitals Leuven. The trial plans to enroll 99,999,999 participants.